A Retrospective Study on Extranodal Lymphoma or Lymphoma of Rare Pathological Types

June 15, 2023 updated by: Zhao Weili, Ruijin Hospital
The aim of this study is to retrospectively collect clinical information on patients with extranodal or rare lymphomas, and to explore the best treatment strategy for these lymphomas in the real-world population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Lymphoma is a highly common malignant tumor in Asia. For specific extra-abdominal sites or rare pathological subtypes of lymphoma, traditional chemotherapy protocols often cannot provide satisfactory results for patients. This study aims to retrospectively collect clinical information on patients with extranodal lymphoma or rare pathological subtype lymphoma, including the distribution of involved sites, clinical and molecular characteristics of different lymphoma subtypes, clinical treatment protocols, and prognosis, to explore the best treatment strategy for these lymphomas in the real-world population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with histologically confirmed diagnosis of non-Hodgkin lymphoma with extranodal involvement or non-Hodgkin lymphoma of rare pathological types attending participating centres.

Description

Inclusion Criteria:

  1. Age ≥ 18 years (including 18 years old).
  2. Patients newly diagnosed with non-Hodgkin lymphoma with extranodal involvement, whether it is primary, secondary, or cannot be determined; Or patients newly diagnosed with non-Hodgkin lymphoma of rare pathological types, including IVLBCL, SMZL, ALCL, AITL, MALTL.
  3. Patients who have received systematic clinical treatment.
  4. Patients with measurable lesions, at least containing one effective evaluation of efficacy.

Exclusion Criteria:

  1. Patients who only receive supportive treatment.
  2. Patients who cannot obtain effective evaluation data of efficacy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Overall Survival (OS) will be defined from the start date of therapy to the date of death from any cause.
Baseline up to data cut-off (up to approximately 1 year)
Progression Free Survival (PFS)
Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Progression-Free Survival (PFS) will be defined from the date of starting therapy and the date of disease progression, relapse or death from any cause.
Baseline up to data cut-off (up to approximately 1 year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical characteristics form
Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Clinical characteristics from data filled into registry forms by physicians and data managers, including but not limited to values of lactate dehydrogenase, clinical stage, performance status, age ≥ 60 years and number and location of extranodal localizations.
Baseline up to data cut-off (up to approximately 1 year)
Biological characteristics form
Time Frame: Baseline up to data cut-off (up to approximately 1 year)
Biological characteristics from data filled into registry forms by physicians and data managers, such as immunohistochemical differences and genetic mutation characteristics of non-hodgkin´s lymphomas.
Baseline up to data cut-off (up to approximately 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital with Nanjing Medical University
Shanxi Province Cancer Hospital
The First Affiliated Hospital of Anhui Medical University
The First Affiliated Hospital of Nanchang University
Chongqing University Cancer Hospital
Peking University People's Hospital
Sun Yat-sen University
Beijing Friendship Hospital
Peking Union Medical College Hospital
Peking University Third Hospital
RenJi Hospital
Henan Cancer Hospital
West China Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Hunan Cancer Hospital
Anhui Provincial Cancer Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Nanfang Hospital of Southern Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Shandong Provincial Hospital
Beijing Hospital
The First Affiliated Hospital of Soochow University
The First Affiliated Hospital of Guangzhou Medical University
Zhujiang Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
The Affiliated Hospital Of Guizhou Medical University
General Hospital of Ningxia Medical University
Wuhan TongJi Hospital
The Affiliated Hospital of Xuzhou Medical University
First Affiliated Hospital of Harbin Medical University
The Second Affiliated Hospital of Dalian Medical University
The First Affiliated Hospital of Xiamen University
Affiliated Hospital of Nantong University
Anshan Central Hospital
Hainan Cancer Hospital
The General Hospital of Northern Theater Command
Fifth Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EXPECT-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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